Events

Recall of CELLAVISION DM96 SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CELLAVISION AB.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63918
  • Event Risk Class
    II
  • Event Initiated Date
    2017-12-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    A bug has been discovered in versions 6.0.1 and 6.0.2 of cellavision dm software where comments are not sent to lis.

Device

CELLAVISION DM96 SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: XU-10020-01 (Lot serial: 31477); Model Catalog: XU-10020-01 (Lot serial: >10 serial numbers-contact mfg); Model Catalog: XU-10127-01 (Lot serial: 33538); Model Catalog: XU-10127-01 (Lot serial: >10 serial numbers-contact mfg); Model Catalog: XU-10288-01 (Lot serial: >10 serial numbers-contact mfg); Model Catalog: XU-10288-01 (Lot serial: 36221)
  • Product Description
    CellaVision DM96;CELLAVISION DM96;CELLAVISION DM1200;CellaVision DM1200;CELLAVISION DM9600;CellaVision DM9600
  • Manufacturer
    CELLAVISION AB

Manufacturer

CELLAVISION AB
  • Manufacturer Address
    LUND
  • Manufacturer Parent Company (2017)
    CellaVision AB
  • Source
    HC